PDFファイル - 医薬品医療機器総合機構
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1. F ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP 10uL N 5OuL2. 1 000 ppm 1 2 1 121 20
3. 2 8 2 8
4. 1000xg 15 2051 oo 2 lt ADVIA Centaur ADVIA Centaur CP 5 0 11 500 mg dL 1000 mg dL ua 20 mg dL AFP 2 1500 mL 0 5 0 1N
5. 215 ngimL 12 5 IU mL ACS 2 Dilution point 1000 ng mL 830 IU mL Dilution factor serum samples 10 20 100 200 ACS 2 Dilution factor 1
6. 20700AMY00118000 m 2015 8 8 2015 1 7 TIII ACS AFP
7. ah h a 5 zu Cu L ADVIA Centaur XP XPT 10 20 100 200 20 ADVIA Centaur CP 10 100 2004 20 2 WIE 2 2
8. an IE ACS 2 2 8C 28 AFP ADVIA Centaur XP XPT
9. m 1 ACS AFP 5 0 mL w AFP 0 13 25 0 mL IAL Eris v AFP id AMR EEC BAS SR ith CT PRL EI 8 2 8 oe 20 1
10. m TERE 1 ADVIA Centaur XP XPT 1 3 1000 ng mL 1 08 830 IU mL ADVIA Centaur CP 1 7 1000 ng mL 1 4 830 IU mL 1 T we 20ngmL B BIT 3 2 3 w w 80 ng mL 30 we 80 ng mL 20 3 gw 5 C V 20 ADVIA Centaur XP XPT A
11. AFP AFP AFP AFP AFP AFP AFP
12. y AFP a 1 3 1 2 ADVIA Centaur ACS D 1 16 lt 0 1 ACS 2 0 1 1
13. 1 14 28H 2 28 14 2 y 1
14. 41 37 3 1 0 0 204 105 19 56 5 19 HERE 80 29 11 20 4 16 93 79 8 5 0 1 64 54 8 2 0 0 40 37 3 0 0 0 78 73 5 0 0 0 18 16 1 1 0 0 99 83 6 3 2 5 60 48 4 2 1 5 64 51 8 5 0 0 224 217 6 1 0 0 3 98 4 8 1 ng mL ADVIA Centaur XP XPT AFP ii 1 3 943 6 ngimL 1 1 783 2 IUmL ADVIA Centaur CP AFP 1 4 866 0 ngimL 1 2 718 8 IUlmL 3 3 RLUs 1 000 000 ng mL 830 000 IUlmL AFP 1000 ng mL 830 IUlmL AFP AFP
15. lt 0 1 ADVIA Centaur CP 1 2 ADVIA Centaur CP 1 3 4 ACS 2 ACS D ACS D ADVIA Centaur XP XPT
16. 28 HAS TEE 1 10 pt dead volume 2 1000 ng mL 830 IU mL
17. 100 5 ADVIA Centaur CP AFP if amp 357 7 500 9ng mL 296 9 415 7 IU mL 6 ACS 2 2 4 8 16 32 95 9 119 6 105 2 ADVIA Centaur XP XPT 35 6 47 4ng mL 29 6 39 3 IU mL AFP 5 21 2 342 4ng mL 17 6 284 2 IU mL AFP 91 9 109 2 99 0 ADVIA Centaur CP 41 3 54 2 ng mL 34 3 45 0 IU mL AFP 5 22 2 378 7ng mL 18 4 314 4 IU mL AFP 91 4 105 0 98 6 ADVIA Centaur XP XPT 7 2 3 4 2 n 113 CV g ml U mL CV CV 16 5 13 7 3 6 4 4 5 7 21 9 18 2 4 0 3 8 6 1 37 3 31 0 3 3 3 9 5 7 67 1 55 7 2 7 3 4 4 9 173 9 144 3 2 8 3 7 5
18. 250pL 370 7 5 37C 9 77 BF 1 WY 300pL 300 uL NV BF Bbound F free AFP RLUs 1 AFP ng mL IUI ml SI 1 ng mL 0 83 IU ML CF 8 70 000 1 ng 0 0143 nmol 2 1858 ACS 180 AFP nglmL 0 8 0 8 1 20 0 20 1 500 0 500 1 1000 0 gt 1000 0 397 389 7 1 0 0 396 391 5 0 0 0
19. 28 14 2 BEER 14 ER 28 Use Beyond ADVIA Centaur CP 28 A 14 2 BEE 14
20. AFP AFP AFP Cu g mL x 100 1300 101 1500 97 330 101 10 99 5 360 101 13 106 C 60 99 1200 100 700 99 CLSI EP7 A27 ACS 180 3 3 AFP AFP a 1 o 1 w
21. 1 2 8 2 4 25 C1 1 3 2 1 6 ACS AFP 500 03305838 Ay Y 5 110764 ACS AFP 100 03974780 1 0262 gt 5000 1500 mL 03852677 ADVIA CentaurXP XPT 112219 1000 300 mL 00497043 1 E ae Fal a Y ADVIA Centaur CP ACS D 04956492 2 672173 1 2x2500 mL ADVIA Centaur XP XPT CP H 03773025 2x1500 mL ADVIA Centaur XP XPT CP 01137199 112351 ACS 2 2x10 mL 07948423 110314 Clinical
22. 0 499 9 414 9 3 1 2 0 5 0 732 0 607 6 3 4 2 0 5 5 ADVIA Centaur CP CLSIEP5 A24 20 1 1 2 1 CV g mL UIML CV CV 27 3 22 7 5 2 5 8 1 1 85 6 71 0 3 6 5 1 6 2 191 1 158 6 4 4 5 6 2 1 000 ng mL 830 IU ML 2 AFP WHO AFP 72 225 56 WHO ADVIA CentaurAFP 0 99 WHO 2 8 ng mL r
23. 0 99 ADVIA Centaur CP AFP 1 01 WHO 3 34 ng mL r 1 00 HIV HBV HCV 2 3 DH lt 2 pH13 ACS 2 ACS D 1
24. 1500 mL 0 25N ADVIA Centaur CP 300mL w AFP u 1 2 1 AFP 2 AFP m ADVIA Centaur ADVIA Centaur 1 CLSI Clinical and Laboratory Standards Institute CLSI EP7 A27 3
25. FP RE 1 3 943 6ng mL 1 1 783 2 IU mL 498 ADVIA Centaur ADVIA Centaur AFP ACS 180 ACS 180 AFP ADVIA Centaur AFP 1 05 ACS 180 AFP 0 3ng mL r 0 99 ADVIA Centaur CP 1 AFP R 1 4 866 0ng mL 1 2 718 8 IU mL 306 ADVIA Centaur CP ADVIA Centaur CP AFP ACS 180 AFP ADVIA Centaur CP AFP 1 01 ACS 180 AFP 0 8ng mL r 0 989 dr a 2 AFP R E 1 7 949 0ng mL 1 4 787 7 IU mL 308 ADVIA Centaur CP AFP ADVIA Centaur AFP ADVIA Centaur CP AFP 0 98 ADVIA Centaur AFP 1 2ng mL r 0 986 ADVIA Centaur XP XPT AFP ig amp 336 3 594 7ng mL 279 1 493 6 IU mL 6 ACS 2 2 4 8 16 32 78 1 117 2
26. and Laboratory Standards Institute formerly NCCLS Proce dures for the Handling and Processing of Blood Specimens Approved Guide line Third Edition Wayne PA Clinical and Laboratory Standards Institute 2004 NCCLS Document H18 A3 Boscato LM Stuart MC Heterophilic antibodies a problem for all immunoassays Clin Chem 1988 34 27 33 Clinical and Laboratory Standards Institute formerly NCCLS How to Define and Determine Reference Intervals in the Clinical Laboratory Approved Guideline Second Edition Wayne PA Clinical and Laboratory Stan dards Institute 2000 NCCLS Document C28 A2 Clinical and Laboratory Standards Institute formerly NCCLS Evalu ation of Precision Performance of Quantitative Measurement Methods Approved Guideline Second Edition Wayne PA Clinical and Laboratory Standards Institute 2004 NCCLS Document EP5 A2 Sizaret Ph Anderson SG The international reference preparation for alphafetoprotein J Biol Standardization 1976 4 149 Sizaret P Breslow N Anderson SG et al Collaborative study of a preparation of human cord serum for its use as a reference in the assay of alpha fetoprotein J Biol Standardization 1975 3 201 23 Clinical and Laboratory Standards Institute formerly NCCLS Inter ference Testing in Clinical Chemistr Approved Guideline Second Edition Wayne PA Clinical and Laboratory Standards Institute 2005 NCCLS document EP7 A2 Sizaret P Equivalence between international un
27. its and mass units of alpha fetoprotein Clin Chimica Acta 1979 96 59 65 03 3493 8400 1 11 1 ADVIA Centaur ACS 180 Siemens 10309979M1_04 ADVIA Centaur 10629809 EN Rev T CP 10629914 Rev E
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